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NCT03860259 · ClinicalTrials.gov registry record · NA
Auriculotherapy for Surgical Pain
A NA study, sponsored by Jacques E. Chelly.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03860259: Completed NA study, sponsored by Jacques E. Chelly.
NCT03860259 is a NA study that has completed, run by Jacques E. Chelly. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860259, a NA study, has completed, sponsored by Jacques E. Chelly.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and elect
Primary Outcome
Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals
Interventions
- DEVICE Auriculotherapy cryopuncture device without nitrogen gas
- DEVICE Auriculotherapy cryopuncture device with nitrogen gas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-01-24 |
| Est. Completion | 2021-09-29 |
| Phase | NA |
What the finished NCT03860259 record still lists
NCT03860259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Auriculotherapy cryopuncture device without nitrogen gas is the first listed.
NCT03860259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03860259 about?
NCT03860259 is a clinical study titled "Auriculotherapy for Surgical Pain". The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depre...
What is the current status of trial NCT03860259?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2020-01-24. Estimated completion is 2021-09-29.
What interventions are being tested in trial NCT03860259?
The interventions under investigation include: Auriculotherapy cryopuncture device without nitrogen gas (DEVICE), Auriculotherapy cryopuncture device with nitrogen gas (DEVICE).
Who is sponsoring clinical trial NCT03860259?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03860259's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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